Factors influencing the quality of Myrmecia pilosula (Jack Jumper) ant venom for use in in vitro and in vivo diagnoses of allergen sensitization and in allergen immunotherapy

Abstract

We have identified factors, which can influence the quality and consistency of JJAV AIs, and provided a framework for appropriate handling, transporting and storage of JJAV to be used for the diagnosis of allergen sensitization and in AIT.

Developments in the field of allergy in 2017 through the eyes of Clinical and Experimental Allergy

“…171 They found good batch to batch consistency but degradation above 40°C. Wanandy and colleagues described how they assessed the consistency of allergenic material and the impact of environmental factors.…”

Pharmaceutical and preclinical evaluation of Advax adjuvant as a dose-sparing strategy for ant venom immunotherapy

“…Chemicals, reagents and consumables used in the experiments were as previously described [16]. Chemicals used in the formulation of JJA VIT products were of pharmacopoeial grade; sucrose and polysorbate 80 from Avantor (Centre Valley, PA, USA), benzyl alcohol from PCCA (Houston, TX, USA), sodium chloride 20% solution from AstraZeneca (North Ryde, NSW, Australia), sodium dihydrogen phosphate solution from Phebra (Lane Cove West, NSW, Australia), disodium hydrogen phosphate from SAFC (St. Louis, MO, USA), 0.9% sodium chloride from Pfizer (West Ryde, NSW, Australia), Water for Injection from Pfizer and Baxter (Old Toongabbie, NSW, Australia).…”

“…Microbiological media and ATCC ® strains microorganisms were from Oxoid (Basingstoke, Hampshire, UK). Pooled positive sera (PPS) with high JJAV-specific positive IgE levels was obtained from JJAV allergic individuals with clinically proven history of allergy, as previously described [16].…”

“…JJAV Active Pharmaceutical Ingredient (API) was prepared as previously described [16] and formulated in 22% sucrose solution to produce clinical grade JJA VIT containing 1.1 mg/mL venom proteins. JJAV diluent solution containing 0.9% sodium chloride, phosphate buffer (pH 6.0; 10 mM), 0.05% polysorbate 80 and 0.9% benzyl alcohol was manufactured at the Pharmacy Department, Royal Hobart Hospital as previously described [17].…”

“…Understanding the stability of JJA VIT and its aggregation potential with Advax microparticles in a combined formulation is essential as aggregation or decomposition of allergen components in JJAV may affect their allergenic potency [16], which has been found to increase with storage in a previous study [17]. The objective of the current study was therefore to explore the stability and aggregation potential of JJA VIT and Advax in a combined formulation as a prelude to a clinical trial of low-dose JJA VIT with Advax.…”